Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
- Conditions
- Platinum-resistant Ovarian Cancer
- Interventions
- Registration Number
- NCT04729608
- Lead Sponsor
- Aravive, Inc.
- Brief Summary
This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 366
- Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- Aged 18 years or older
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
- Platinum-resistant disease (defined as progression within โค6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
- Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
- Received at least 1 but not more than 4 prior therapy regimens.
Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.
- Measurable disease according to RECIST v1.1 criteria
- Normal gastrointestinal function.
- At least 28 days between termination of prior anticancer or hormonal therapy and first administration of batiraxcept.
- Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.
- Tumors in the breast or bone
- Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
- Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
- Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
- Received prior therapy with PAC in the platinum-resistant recurrent setting
- Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of batiraxcept/placebo
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo+PAC Placebo Placebo-controlled arm with PAC Batiraxcept+PAC Paclitaxel Combination of batiraxcept and PAC Placebo+PAC Paclitaxel Placebo-controlled arm with PAC Batiraxcept+PAC Batiraxcept Combination of batiraxcept and PAC
- Primary Outcome Measures
Name Time Method Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC 4 months PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.
- Secondary Outcome Measures
Name Time Method Overall survival 20 months Time following the treatment until death
Trial Locations
- Locations (149)
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
๐บ๐ธLos Angeles, California, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
๐บ๐ธDallas, Texas, United States
Columbus NCORP
๐บ๐ธColumbus, Ohio, United States
Women's Cancer Center of Nevada
๐บ๐ธLas Vegas, Nevada, United States
Duke Cancer Center
๐บ๐ธDurham, North Carolina, United States
Stephenson Cancer Center - University of Oklahoma
๐บ๐ธOklahoma City, Oklahoma, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
Wojewรณdzkie Wielospecjalistyczne Centrum Onkologii
๐ต๐ฑลรณdลบ, Poland
Baystate Medical Center
๐บ๐ธSpringfield, Massachusetts, United States
Women & Infants Hospital of Rhode Island
๐บ๐ธProvidence, Rhode Island, United States
LTD Caucasus Medical Centre
๐ฌ๐ชTbilisi, Georgia
Providence Cancer Institute Franz Clinic
๐บ๐ธPortland, Oregon, United States
Southeastern Regional Medical Center, LLC
๐บ๐ธNewnan, Georgia, United States
University of South Alabama Mitchell Cancer Institute
๐บ๐ธMobile, Alabama, United States
Disney Family Cancer Center
๐บ๐ธBurbank, California, United States
Stanford Women's Cancer Center
๐บ๐ธPalo Alto, California, United States
Olive View UCLA Medical Center
๐บ๐ธSylmar, California, United States
Hartford Hospital
๐บ๐ธHartford, Connecticut, United States
Florida Cancer Specialists
๐บ๐ธWest Palm Beach, Florida, United States
Northeast Georgia Medical Center
๐บ๐ธGainesville, Georgia, United States
Dr. Sudarshan K. Sharma, Ltd.
๐บ๐ธHinsdale, Illinois, United States
Willis-Knighton Physician Network
๐บ๐ธShreveport, Louisiana, United States
Baptist Health Lexington
๐บ๐ธLexington, Kentucky, United States
Maine Medical Partners - Women's Health - Division of Gynecologic Oncology
๐บ๐ธScarborough, Maine, United States
Greater Baltimore Medical Center
๐บ๐ธBaltimore, Maryland, United States
Holy Cross Hospital
๐บ๐ธSilver Spring, Maryland, United States
Dana Farber Cancer Institute (DFCI)
๐บ๐ธBoston, Massachusetts, United States
Center of Hope
๐บ๐ธReno, Nevada, United States
Metro Minnesota Community Oncology Research Consortium
๐บ๐ธSaint Louis Park, Minnesota, United States
Mercy Hospital, David C Pratt Cancer Center
๐บ๐ธSaint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
๐บ๐ธNew Brunswick, New Jersey, United States
Stony Brook University Hospital
๐บ๐ธStony Brook, New York, United States
Optimum Clinical Research Group, LLC
๐บ๐ธAlbuquerque, New Mexico, United States
The Blavatnik Family-Chelsea Medical Center at Mount Sinai
๐บ๐ธNew York, New York, United States
North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists
๐บ๐ธPort Jefferson Station, New York, United States
Miami Valley Hospital South
๐บ๐ธCenterville, Ohio, United States
University of Cincinnati
๐บ๐ธCincinnati, Ohio, United States
Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run
๐บ๐ธColumbus, Ohio, United States
Kettering Cancer Center
๐บ๐ธKettering, Ohio, United States
University of Pennsylvania Health System
๐บ๐ธPhiladelphia, Pennsylvania, United States
Lankenau Medical Center
๐บ๐ธWynnewood, Pennsylvania, United States
University of Tennessee
๐บ๐ธKnoxville, Tennessee, United States
Chattanooga's Program in Women's Oncology
๐บ๐ธChattanooga, Tennessee, United States
Tennessee Oncology PLLC
๐บ๐ธNashville, Tennessee, United States
Carilion Clinic Gynecology Oncology
๐บ๐ธRoanoke, Virginia, United States
Pro Healthcare Waukesha Memorial Hospital
๐บ๐ธWaukesha, Wisconsin, United States
Swedish Cancer Institute
๐บ๐ธSeattle, Washington, United States
Seattle Cancer Care Alliance
๐บ๐ธSeattle, Washington, United States
AZ St Jan Brugge
๐ง๐ชBrugge, Belgium
UCL St Luc
๐ง๐ชBruxelles, Belgium
AZ Maria Middelares
๐ง๐ชGent, Belgium
UZ Leuven
๐ง๐ชLeuven, Belgium
CHC Liege
๐ง๐ชLiege, Belgium
CHU UCL Namur St. Elisabeth
๐ง๐ชNamur, Belgium
The Second Affiliated Hospital of Zhejiang University School of Medicine
๐จ๐ณZhejiang, Hangzhou Province, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
๐จ๐ณWuhan, Hubei, China
Clinical Research Unit, Jewish General Hospital
๐จ๐ฆMontrรฉal, Quebec, Canada
Sunnybrook Research Institute
๐จ๐ฆToronto, Ontario, Canada
First Affiliated Hospital of Soochow University
๐จ๐ณSuzhou, Jiangsu, China
Sun Yat-sen Memorial Hospital
๐จ๐ณGuangzhou, Yuexiu District, Guangdong Province, China
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
๐จ๐ณXi'an, Shanxi, China
Fudan University Shanghai Cancer Hospital
๐จ๐ณShanghai, Xuhui District, China
Nantong Tumor Hospital
๐จ๐ณNantong, Tongzhou District, Jiangsu Province, China
Fakultni Nemocnice Olomouc
๐จ๐ฟOlomouc, Czechia
UG Prague
๐จ๐ฟPrague, Czechia
ICANS
๐ซ๐ทStrasbourg, France
LTD Tbilisi Oncology
๐ฌ๐ชTbilisi, Georgia
IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"
๐ฎ๐นMeldola, Italy
VHIO
๐ช๐ธBarcelona, Spain
IEO - Istituto Europeo di Oncologia
๐ฎ๐นMilan, Italy
Nuovo Ospedale Santo Stefano di Prato
๐ฎ๐นPrato, Italy
Szpitale Pomorskie Sp. z o.o.
๐ต๐ฑGdynia, Poland
SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej
๐ต๐ฑSzczecin, Poland
UCK Centrum Medycyny
๐ต๐ฑGdaลsk, Poland
Maria Sklodowska - Curie Instytute Oncolgy Center
๐ต๐ฑWarsaw, Poland
Hospital Universitario Reina Sofia (Provincial)
๐ช๐ธCordoba, Spain
Hospital San Pedro de Alcรกntara
๐ช๐ธCรกceres, Spain
Hospital General Universitario de Elche
๐ช๐ธElche, Spain
Institut Catala d'Oncologia
๐ช๐ธGirona, Spain
ICO
๐ช๐ธHospitalet de Llobregat, Spain
Hospital Son Espases
๐ช๐ธPalma De Mallorca, Spain
Clinica Universidad de Navarra
๐ช๐ธPamplona, Spain
IVO (Instituto Valenciano de Oncologรญa)
๐ช๐ธValencia, Spain
Hospital La Paz
๐ช๐ธMadrid, Spain
Royal United Hospital Bath NHS Foundation Trust
๐ฌ๐งBath, United Kingdom
The Royal Marsden NHS Foundation Trust (Fulham Road)
๐ฌ๐งLondon, United Kingdom
Clatterbridge Cancer Centre
๐ฌ๐งLiverpool, United Kingdom
North Shore University Health System
๐บ๐ธEvanston, Illinois, United States
Midwestern Regional Medical Center, LLC
๐บ๐ธZion, Illinois, United States
Magee Women's Hospital of UPMC
๐บ๐ธPittsburgh, Pennsylvania, United States
West Penn Hospital
๐บ๐ธPittsburgh, Pennsylvania, United States
The Valley Hospital - Luckow Pavilion
๐บ๐ธParamus, New Jersey, United States
University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center
๐บ๐ธSan Francisco, California, United States
West Virginia University
๐บ๐ธMorgantown, West Virginia, United States
University of Wisconsin Clinical Science Center
๐บ๐ธMadison, Wisconsin, United States
UCLA Women's Health Clinical Research Unit
๐บ๐ธLos Angeles, California, United States
UC Irvine Health-Chao Family Comprehensive Cancer Center
๐บ๐ธOrange, California, United States
Banner MD Anderson Cancer Center/North Colorado Medical Center
๐บ๐ธGreeley, Colorado, United States
Georgia Cancer Center at Augusta University
๐บ๐ธAugusta, Georgia, United States
Baptist MD Anderson Cancer Center
๐บ๐ธJacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
๐บ๐ธMiami Beach, Florida, United States
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.
๐บ๐ธSavannah, Georgia, United States
The University of Chicago Medical Center
๐บ๐ธChicago, Illinois, United States
Community Health Network
๐บ๐ธIndianapolis, Indiana, United States
St. Elizabeth Healthcare
๐บ๐ธEdgewood, Kentucky, United States
St Vincent Hospital and Healthcare Center
๐บ๐ธIndianapolis, Indiana, United States
Women's Cancer Care
๐บ๐ธCovington, Louisiana, United States
Beth Israel Hospital
๐บ๐ธBoston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
๐บ๐ธSouth Weymouth, Massachusetts, United States
Washington University School of Medicine - Division of Gynecologic Oncology
๐บ๐ธSaint Louis, Missouri, United States
Billings Clinic
๐บ๐ธBillings, Montana, United States
Holy Name Medical Center
๐บ๐ธTeaneck, New Jersey, United States
Gabrail Cancer Center Research
๐บ๐ธCanton, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC
๐บ๐ธTulsa, Oklahoma, United States
Sanford Gynecology Oncology Clinic
๐บ๐ธSioux Falls, South Dakota, United States
ZNA Middelheim
๐ง๐ชAntwerpen, Belgium
CHA Libramont
๐ง๐ชLibramont, Belgium
Princess Margaret Cancer Center
๐จ๐ฆToronto, Ontario, Canada
Peking University Cancer Hospital
๐จ๐ณBeijing, Haidian District, China
Tianjin Cancer Hospital
๐จ๐ณTianjin, Hexi District, China
Qilu Hospital Of Shandong University
๐จ๐ณJinan, Shandong, China
The First Affiliated Hospital of Zhejiang University School of Medicine
๐จ๐ณZhejiang, Shangcheng District, Hangzhou Province, China
The Second Hospital of Shanxi Medical University
๐จ๐ณTaiyuan, Xinghualing District, Shanxi Province, China
Hunan Cancer Hospital
๐จ๐ณChangsha, Yuelu District, Hunan Province, China
Sun Yat-sen University Cancer Center
๐จ๐ณGuangzhou, Yuexiu District, China
Fakul Nemocnice Hradec Kralove
๐จ๐ฟHradec Krรกlovรฉ, Czechia
FN Ostrava-Poruba
๐จ๐ฟOstrava, Czechia
LTD High Technology Hospital Medcenter
๐ฌ๐ชBatumi, Georgia
LTD Aversi Clinic
๐ฌ๐ชTbilisi, Georgia
LTD Innova
๐ฌ๐ชTbilisi, Georgia
LTD Consilium Medulla - Multiprofile Clinic
๐ฌ๐ชTbilisi, Georgia
Policlinico S. Orsola-Malpighi - SSD Oncologia Medica
๐ฎ๐นBologna, Italy
Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia
๐ฎ๐นCandiolo, Italy
IRCCS
๐ฎ๐นNapoli, Italy
Ospedale "Vito Fazzi" - ASL Lecce
๐ฎ๐นLecce, Italy
SC Oncologia - Ospedale San Luca
๐ฎ๐นLucca, Italy
Fondazione Policlinico "Agostino Gemelli" IRCCS
๐ฎ๐นRome, Italy
South West Wales Cancer Institute
๐ฌ๐งSwansea, United Kingdom
The Royal Marsden NHS Foundation Trust (Sutton)
๐ฌ๐งLondon, United Kingdom
University of Michigan
๐บ๐ธAnn Arbor, Michigan, United States
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
First Health of the Carolinas
๐บ๐ธPinehurst, North Carolina, United States
Abington Memorial Hospital, Hanjani Institute for Gyn Onc
๐บ๐ธWillow Grove, Pennsylvania, United States
Cox Health
๐บ๐ธSpringfield, Missouri, United States
Yale University School of Medicine
๐บ๐ธNew Haven, Connecticut, United States
AdventHealth Gynecologic Oncology
๐บ๐ธOrlando, Florida, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Virginia Commonwealth University
๐บ๐ธRichmond, Virginia, United States